Actively Recruiting
SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Led by University of Utah · Updated on 2025-03-27
500
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
T
The Geneva Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a single-session mindfulness-based intervention (MBI) and an intensive 8-week MBI-Mindfulness-Oriented Recovery Enhancement (MORE) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. Aim 1: Evaluate the extent to which a brief preoperative MBI improves TKA patients' postoperative musculoskeletal health and reduces chronic opioid use. Aim 2: Evaluate the extent to which an intensive MBI (MORE) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. Aim 3: (A) Determine patient baseline characteristics that moderate MBI treatment responses. (B) Quantify the degree to which the impact of Phase 1 and 2 MBIs on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (HRV).
CONDITIONS
Official Title
SMART Embedded Intervention for Military Postsurgical Engagement Readiness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to undergo unilateral total knee arthroplasty (TKA) at one of the study sites
- TRICARE beneficiary
- Ability to complete study procedures in English
You will not qualify if you...
- Cognitive impairment preventing completion of study procedures
- Previous formal mindfulness training (e.g., MBSR, MBCT)
- Severe, active suicidality
- Contralateral total knee arthroplasty in past 3 months or planned during study
- Current cancer diagnosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Actively Recruiting
Research Team
R
Rachel Mayhew
CONTACT
T
Tina Greenlee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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